Virtual Reality for Anxiolysis and Pharmacological Sparing

Официальное название

Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is: Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia? Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device. Participants will be randomly assigned to either a virtual reality (intervention) group or a control group. * The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice. * Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.

Подробное описание

Virtual reality (VR) has carved out a growing place for itself in our leisure activities, video games and even in medicine. Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care (e.g. wound care, dental care, venous access). While the population most frequently investigated is pediatric, the benefits can be extended to other populations. The operating room is uncommon due to the type of procedure and the older patient profile. Yet, with the democratization of regional and neuraxial anesthesia, VR could improve the patient experience in the operating room.

The main objective of this study is to explore the impact of VR on intravenous (I.V.) sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block. The hypothesis is that VR will serve as an effective distraction in the operative context, reducing the need for pharmacology. In parallel, multiple secondary objectives will also be explored, such as the evaluation of the tolerance to the VR headset, the impact of the chosen type of scenario on the primary outcome, the incidence of adverse effects, the variation of the Nociception Level Index (NOL index) in awake patients as well as overall patient satisfaction.

This single center, open-label, randomized controlled trial will be conducted in a Canadian academic hospital. 100 patients above the age of 18 years undergoing breast surgery (mastectomy, reduction, augmentation, reconstruction, etc.) under regional anesthesia, specifically paravertebral block, will be included in this study. Patients will be randomized either to the intervention group or the control group. The intervention group will have a VR helmet and the control group a standard treatment. Both will have access to patient-controlled sedation (PCS), self-administering their own sedation under clinical observation. Patients in the VR group will be able to choose, before the procedure begins, between 3 different VR environments and will also be allowed to switch between these environments during the surgery. The primary outcome of this study will be the time-weighted dose of propofol (sedative) self-administered during the procedure. Secondary outcomes will include patient satisfaction, premature removal of VR helmet, presence of nausea, desaturation, hypotension and post-anesthesia monitoring time.

Вмешательства

• Устройство Virtual reality headset
  A brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient
• Другое Standard of care
  Standard of care in anesthesia with patient-controlled sedation.

Первичные конечные точки

• Propofol self-administration [Срок оценки: Between 1 hour and 3 hours]

Вторичные конечные точки (12)

• Preoperative anxiety [Срок оценки: Up to 1 hour]
• Remifentanil administration [Срок оценки: Between 1 hour and 3 hours]
• Ketamine administration [Срок оценки: Between 1 hour and 3 hours]
• Adverse events [Срок оценки: Between 1 hour and 3 hours]
• Scenario switches [Срок оценки: Between 1 hour and 3 hours]
• Virtual reality usage [Срок оценки: Between 1 hour and 3 hours]
• Virtual reality usage per first scenario [Срок оценки: Between 1 hour and 3 hours]
• Virtual reality headset removal [Срок оценки: Between 1 hour and 3 hours]
• Post-Anesthesia Care Unit stay [Срок оценки: Between 30 minutes and 2 hours]
• Enthusiasm at the idea of using virtual reality [Срок оценки: Up to 1 hour]
• Ease of use [Срок оценки: Between 30 minutes and 2 hours]
• Enjoyment of the first scenario chosen [Срок оценки: Between 30 minutes and 2 hours]

Критерии участия

Критерии включения

• Fully consented female patients above the age of 18 years;
• Undergoing elective, awake, breast surgery performed under paravertebral block.

Критерии исключения

• Hearing or visual impairment;
• History of epilepsy, seizure or severe dizziness;
• Severe mental impairment;
• Recent eye or facial surgery or wounds;
• Inability to use the VR hand controller.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal — Montreal East

Публикации

• Boutin J, Kamoonpuri J, Faieghi R, Chung J, de Ribaupierre S, Eagleson R. Smart haptic gloves for virtual reality surgery simulation: a pilot study on external ventricular drain training. Front Robot AI. 2024 Jan 10;10:1273631. doi: 10.3389/frobt.2023.1273631. eCollection 2023. PMID 38269073
• Boyce L, Jordan C, Egan T, Sivaprakasam R. Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. Pain. 2024 Apr 1;165(4):741-752. doi: 10.1097/j.pain.0000000000003086. Epub 2023 Oct 23. PMID 37870233
• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165. PMID 31136330
• Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17. PMID 35976578
• Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021. PMID 34908872
• Hitching R, Hoffman HG, Garcia-Palacios A, Adamson MM, Madrigal E, Alhalabi W, Alhudali A, Sampaio M, Peterson B, Fontenot MR, Mason KP. The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. J Clin Med. 2023 Jan 20;12(3):843. doi: 10.3390/jcm12030843. PMID 36769490
• Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020. PMID 32092098
• Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361. PMID 29750696

Идентификаторы

NCT: NCT06522711 · 2025-3802

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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